Conflict-of-interest rules spur $23M investment

It cost 71 medical schools and teaching hospitals $23 million to implement conflict-of-interest requirements that the Department of Health and Human Services put in place four years ago, according to an analysis by the Association of American Medical Colleges.

The new rules require that researchers involved in federally funded projects disclose all financial interests, not just those associated with the government-funded research. The rules also lowered the financial reporting threshold from $10,000 to $5,000 and required that institutions, as opposed to researchers, determine if there was a conflict of interest or the appearance of a conflict of interest.

Heather Pierce, senior director for science policy and regulatory counsel for AAMC, told MM&M that software accounted for much of the initial outlay. Redesigning the reporting requirements and educating teaching faculty about the new rules also contributed to the lump sum.

The 2011 rules apply to researchers participating in federally funded research, and Pierce noted that no institution created a process from scratch because these rules upgraded standards that have been in place since 1995. The AAMC said in its report that the goal of HHS's revision was to create a framework that could “provide a reasonable expectation” that publicly funded research would be unbiased.

The institutions accrued the $23 million while implementing the rules between 2011 and 2012.

AAMC found the lower financial threshold of $5,000 meant the number of disclosures jumped at 79% of institutions, but less than 45% of those reported disclosures were determined to be conflicts of interest.

A financial conflict of interest is one that could be perceived as influencing research. Researchers' conflicts of interest also include a spouse's or child's investments or other financial ties.

Although the number of disclosures jumped, the number of disclosures that were determined to be financial conflicts of interest fell from 4.8% to 1.4% after the rules were in place.

Despite a significant increase in the amount of data, only five medical schools and hospitals saw the number of financial conflicts of interest rise by 20 or more.

The data compared pre- and post-implementation numbers and do not reveal how and if the reporting requirements changed researchers' behaviors. With results in hand, institutions are asking if it was the best use of $23 million dollars and if it had an impact on public trust, Pierce said.